Biofourmis, a Singapore-based health-tech startup, has received FDA clearance for its cloud-based software, RhythmAnalytics, which helps healthcare professionals in detecting cardiac arrhythmia, or irregular heartbeat.
The cloud-based software uses enhanced deep learning to detect over 15 types of cardiac arrhythmia with beat-by-beat morphology computation that includes ventricular arrhythmias, ventricular ectopic beats and all non-paced arrhythmias including Atrial Fibrillation (AFib).
The AI-models were trained using over a million ECG recordings collected using various FDA-cleared ECG monitoring wearables. ECG recordings were collected from patients who have a history of cardiac arrhythmia using ambulatory ECG monitoring devices like the ePatch extended holder monitor from BioTelemetry, which was the same cardiac monitor used in Apple’s heart study, says a press release.
In a recent arXiv paper, the company demonstrated cardiologist-level arrhythmia detection and classification using a novel-deep learning architecture, which was submitted to the FDA to demonstrate clinical evidence in addition to various other clinical trials data. Over 120,000 single-lead ECG episodes were used to train the neural network with over 30 distinctive cardiac arrhythmias. The company demonstrated that RhythmAnalytics outperforms two other similar deep learning systems 2,3 as well as a panel of cardiologists with Sensitivity of 90.8%, Specificity of 98.2% and an overall F1 score of 0.834.
“Comprehensive diagnosis of a patient’s cardiac health requires longer continuous monitoring and full characterization of multiple arrhythmias. We are on a mission of predicting and preventing serious medical events using software-based therapeutic intervention and RhythmAnalytics is an integral part of our Digital Therapeutics platform that would enable prescription of the right dose, to the right patient at the right time,” said Kuldeep Singh Rajput, Founder and Chief Executive Officer of Biofourmis. “We are excited about this milestone and look forward to using RhythmAnalytics to enable clinicians to detect a wide range of cardiac arrhythmias and provide appropriate treatment and therapy.”
Biofourmis plans to offer RhythmAnalytics cloud-based API as Software-as-a-Service (SaaS) to cardiac monitoring organizations to improve the accuracy and scalability of their ECG analysis, thereby improving throughput and efficiencies in their cardiac monitoring centers.
Dr. Maulik Majmudar, a cardiologist and a member of Biofourmis’ clinical advisory board, said:
“Diagnostic interpretation of ambulatory ECGs are not only resource intensive but can also carry high rates of diagnostic errors. Given the interest in, and availability of, OTC consumer-focused ECG acquisition devices on the market today, there is a growing need for rapid, automated, and highly accurate interpretation of single-lead ECGs for a wide array of cardiac rhythm disorders. The FDA-cleared RhythmAnalytics platform directly addresses that need.”
Biofourmis also announced its partnership with Brigham and Women’s Hospital in November 2018, where RhythmAnalytics is currently being used to continuously monitor for cardiac arrhythmias and manage patients at home, at Brigham’s Home Hospital Program. The patient numbers have doubled on a month-on-month basis.